(27 days)
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
The guiding catheter is a flexible plastic tube featuring a luer hub, a strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the design verification and substantial equivalence of the Convey™ 7F and 8F Guiding Catheters to predicate devices (Convey™ 5F and 6F). It lists various in-vitro performance tests that were conducted to ensure the device conforms to requirements. However, it does not explicitly state quantitative acceptance criteria or numerical performance results for each test. Instead, it implies that the device successfully met the requirements through these tests to establish substantial equivalence.
Therefore, the table below will list the tests performed, as these represent the areas where acceptance would have been determined, but will note the absence of explicit quantitative criteria or reported performance values in the provided document.
| Acceptance Criterion (Test Performed) | Reported Device Performance (as implied by document) |
|---|---|
| Visual Inspection | Conforms to requirements |
| Shape Conformance & Shape Retention | Conforms to requirements |
| Outer Diameter | Conforms to requirements |
| Inner Diameter | Conforms to requirements |
| Usable Catheter Length | Conforms to requirements |
| Side Hole diameter & positioning | Conforms to requirements |
| C-Kink (Bending Kink Diameter) | Conforms to requirements |
| Euler Kink (Axial Kink Displacement) | Conforms to requirements |
| Radial Stiffness (Collapse) | Conforms to requirements |
| Three Point Bending Test (Bending Stiffness Body) | Conforms to requirements |
| Pull Force Test (after simulated use) | Conforms to requirements |
| Coating location & length | Conforms to requirements |
| Coating Integrity - Outer Friction & Wear functional test | Conforms to requirements |
| Coating Integrity (after simulated use) | Conforms to requirements |
| Torque Strength (after simulated use) | Conforms to requirements |
| Body Strength / Burst Pressure test | Conforms to requirements |
| Particulate testing | Conforms to requirements |
| Radiopacity / Visibility testing | Conforms to requirements |
| Bacterial Endotoxin-Mediated Pyrogenicity Testing | Conforms to requirements |
| Bioburden testing | Conforms to requirements |
| Ethylene Oxide Residual Testing | Conforms to requirements |
| ISO 10993-4: Haemocompatibility (Hemolysis, In vitro Haemocompatibility, Coagulation) | Conforms to requirements |
| ISO 10993-5: Cytotoxicity - MEM-elution | Conforms to requirements |
| ISO 10993-7: Ethylene Oxide Sterilization Residuals | Conforms to requirements |
| ISO 10993-10: Sensitization | Conforms to requirements |
| ISO 10993-10: Irritation / Intracutaneous Reactivity | Conforms to requirements |
| ISO 10993-11: Acute Systemic Toxicity | Conforms to requirements |
| ISO 10993-11: Material Mediated Pyrogenicity | Conforms to requirements |
| USP <661>: Packaging Plastic Containers Leachables | Conforms to requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "The following in-vitro performance tests... were completed of the 7F & 8F Convey Guiding Catheter." However, it does not specify the number of units tested (sample size) for each of these non-clinical, in-vitro (bench) tests.
- Data Provenance: The tests are described as "non-clinical design verification (bench) tests." The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's bench testing for a new device, it would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable / not provided in the document. The studies described are non-clinical, bench-top performance tests, sterility tests, and biocompatibility tests. These do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI studies do. The ground truth for these tests would be the established scientific and engineering standards and methods for assessing material properties and device performance.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) to establish a consensus ground truth. The studies cited are non-clinical, bench tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Since the modifications do not have an impact on the indications for use and on the safety and performance of the device, a Clinical Evaluation Study was not regarded for these devices." This indicates no human clinical studies were performed for the 7F and 8F guiding catheters. Furthermore, this device is a physical medical device (catheter), not an AI algorithm, so the concept of human readers improving with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical guiding catheter, not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (performance, sterility, biocompatibility), the "ground truth" is based on:
- Established scientific and engineering principles: for physical performance tests (e.g., kink resistance, stiffness, strength, dimensions).
- International standards (e.g., ISO 10993) and USP pharmacopeia tests: for biocompatibility, sterility, and endotoxin testing.
- Manufacturing specifications: for attributes like visual inspection, dimensions, coating properties, etc.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device. It does not use a "training set" in the context of machine learning or AI. The design and validation are based on engineering principles and regulatory standards rather than data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device in this context.
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510(k) Summary
per 21 CFR §807.92
| Submitter'sNameAddress | PendraCare International B.V.Van der Waalspark 229351 VC LeekThe Netherlands | AUG 1 2 2013 |
|---|---|---|
| FDA Establishment Registration Number 3005635992Owner / Operator Number: 10041705 | ||
| Contact Name &Information | Bert Roossien, MSc, PhD.Manager Quality Assurance & Regulatory AffairsPendraCare International B.V.Van der Waalspark 229351 VC LeekThe Netherlands | |
| Phone: +31 594 554 077 (direct)Phone: +31 594 510 755 (general)Fax: +31 594 510 769e-mail: broossien@pendracare.com | ||
| Date prepared | 11 July, 2013 | |
| Proprietary Name | Convey™ Guiding Catheter | |
| Common Name | Percutaneous Catheter | |
| Classification | Class II, 21 CFR 870.1250 | |
| Review Panel | Cardiovascular | |
| Product Code | DQY | |
| Subject Devices | Convey™ 7F Guiding CatheterConvey™ 8F Guiding Catheter | |
| Predicate Devices | Convey™ 5F Guiding Catheter (K120585; August 8, 2012)Convey™ 6F Guiding Catheter (K120585; August 8, 2012) |
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The guiding catheter is a flexible plastic tube featuring a luer hub, a strain Device relief, a body, an intermediate tip, and a soft tip. The body and the Description intermediate tip exist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and / or therapeutic (interventional) devices within the vascular system. The distal section of the catheter has a variety of preformed shapes (e.g., Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multipurpose, hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "inline" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded. The Convey Guiding Catheter is designed to provide a pathway through Intended Use of which therapeutic and diagnostic devices are introduced. The Convey Device Guiding Catheter is intended to be used in the coronary or peripheral vascular system. The Convey Guiding Catheter is designed to provide a pathway through Indications for which therapeutic and diagnostic devices are introduced. The Convey Use Guiding Catheter is intended to be used in the coronary or peripheral vascular system. The Convey™ 7F Guiding Catheter and Convey™ 8F Guiding Catheter Substantial incorporate substantially equivalent device materials and design, Equivalence packaging materials and design, intended use, fundamental technology (operating principle & mechanism of action), labeling and manufacturing processes and sterilization process as those featured in the legally marketed predicate devices, the Convey™ 5F Guiding Catheter and Convey™ 6F Guiding Catheter (K120585, clearance: August 8, 2012).
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| Summary ofNon-clinicalTesting | To support a determination of substantial equivalence, data was collectedfrom non-clinical design verification (bench) tests. The results providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. | |
|---|---|---|
| The following in-vitro performance tests (following simulated use, ifapplicable, were completed of the 7F & 8F Convey Guiding Catheter:Visual Inspection,●Shape Conformance & Shape Retention,●Outer Diameter,�Inner Diameter,Usable Catheter Length,●Side Hole diameter & positioning,�C-Kink (Bending Kink Diameter),�Euler Kink (Axial Kink Displacement),●Radial Stiffness (Collapse),●Three Point Bending Test (Bending Stiffness Body),●Pull Force Test (after simulated use),Coating location & length●Coating Integrity - Outer Friction & Wear functional test,Coating Integrity (after simulated use),Torque Strength (after simulated use),�Body Strength / Burst Pressure test,Particulate testing,Radiopacity / Visibility testing.� | ||
| Summary ofSterility Testing | Bacterial Endotoxin-Mediated Pyrogenicity Testing,Bioburden testing,●Ethylene Oxide Residual Testing.● | |
| Summary ofBiocompatibilityTesting | The Biocompatibility for the 7F & 8F Convey Guiding Catheter wasleveraged from the biocompatibility tests completed on the 5F & 6FConvey™ Guiding Catheter. The following tests were conducted:ISO 10993-4: Haemocompatibility:�o Hemolysiso In vitro HaemocompatibilityCoagulation Tests Prothrombin Time Assay-PTo Coagulation Unactivated Partial Thromboplastin Time Assay-UPISO 10993-5: Cytotoxicity - MEM-elution (USP<87>)ISO 10993-7: Ethylene Oxide Sterilization Residuals●ISO 10993-10: Sensitization (USP<1184>)●ISO 10993-10: Irritation / Intracutaneous Reactivity (USP <88>)●ISO 10993-11: Acute Systemic Toxicity (USP <88>)●ISO 10993-11: Material Mediated Pyrogenicity (USP <151>)◆USP <661>: Packaging Plastic Containers Leachables |
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| Summary ofClinical Testing | Since the modifications do not have an impact on the indications for useand on the safety and performance of the device, a Clinical EvaluationStudy was not regarded for these devices. |
|---|---|
| Conclusion | In summary, the modifications in the subject devices Convey™ 7FGuiding Catheter and Convey™ 8F Guiding Catheter do not affect theintended use and does not alter the fundamental scientific technology ofthe device. The subject devices Convey™ 7F Guiding Catheter andConvey™ 8F Guiding Catheter are substantial equivalent to the predicatedevices Convey™ 5F Guiding Catheter (K120585, dated 8 August 2012)and Convey™ 6F Guiding Catheter (K120585, dated 8 August 2012) withrespect to the intended use, fundamental technology, i.e., operatingprinciple, device materials, design, packaging materials & configuration,labeling, manufacturing & sterilization processes and sterility assurancelevel. |
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2013
Pendracare International, B.V. % Mr. Tom Nolan Managing Director Corvitex Corporation 7205 Laketree Dr Raleigh, NC 27615
K132197 Re:
Trade/Device Name: Convey™ 7F Guiding Catheter, Convey™ 8F Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 11, 2013 Received: July 16, 2013
Dear Mr. Nolan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1f your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2- Mr. Tom Nolan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillerman
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Convey™ 7F Guiding Catheter, Device Name:
Convey™ 8F Guiding Catheter
Indications for Use:
The Convey Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Convey Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann
(Division Sign-Off) Division of Cardiovascular Devices K132197 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).